Table 1.
Incidence of patients with two or more perceptions of excessive treatment and do-not-intubate and resuscitate order in the 10 participating departments over one week pilot study (conducted in July 2019).
Fig 1.
Schedule of enrolment, interventions and assessments.
Fig 2.
Theoretical background on the primary endpoints.
The quality of medical ethical decision-making will be assessed objectively via the incidence of written Do-Not-Intubate and Resuscitate (DNIR) orders in patients potentially receiving excessive treatment during their first hospitalization and subjectively via the Ethical Decision-Making Climate Questionnaire (EDMCQ) [4] that will be filled out by the doctors and nurses in the team one month prior and after the 12-months study period. The EDMCQ is 32-item validated questionnaire consists of 7 main domains or factors: factor F1 “self-reflective and empowering leadership of doctors”, F2 “open and interdisciplinary reflection”, F3 “not avoiding end-of-life decisions”, F4 “mutual respect within the interdisciplinary team”, F5 “active involvement of nurses in end-of-life care and decision-making”, F6 “active decision-making by doctors”, F7 “ethical awareness”. We expect that an effect on individual decision-making by doctors would affect the incidence of written DNIR orders both directly, and indirectly via F3 and F6. We expect that effect on collective decision-making in team would affect F1, which in turn affects all other EDMCQ factors and via these, the incidence of written DNIR orders. Both null hypotheses that will be tested express no change (as opposed to change).
Table 2.
Overview of collected data and timelines: Primary outcomes and secondary outcomes on patient level.
Table 3.
Overview of collected data and timelines: Secondary outcomes on family, clinician and societal level.
Table 4.
Overview of collected data and timelines: Tertiary outcomes*.
Fig 3.
Trial design (stepped wedge cluster randomized controlled trial).
Based on the results of a pilot study (Table 1), we expect that 4 patients per ward per week will be identified by clinicians as potentially receiving excessive care; expanded to 1 month and 10 wards this yields to 160 patients. Taking to account that one in eight patients might be re-admissions and/or patients with length of stay of more than one week, we drop this total amount to 140, of whom 88 without a DNIR code over 10 departments. This yields to 9 patients and 18 coaching sessions (one junior and one senior doctor per patient) per month per department. As 2 to 5 departments will have the intervention at the same time, the expected number of coaching sessions varies between 36 and 90 sessions per month. The black bars indicate the intervention period across all 10 departments. All 10 departments were randomly assigned to start a 4-month coaching period in month k = 1,…,10 following a stratified design. In particular, the 3 departments with the highest incidence of written DNIR orders (based on historical data, Table 1) were randomly assigned to start the intervention in months 2, 4 and 6 (each time together with another ward). The 7 other wards were randomly assigned to start the intervention. Subsequently, departments in which senior doctors remain in charge of their own hospitalized patients (in contrast to departments in which one senior doctor is in charge of all hospitalized patients on a specific ward) were spread in order to reduce the workload of the coach. One month was added to compensate for the absence of the coach for whatever reason.